CFDA Released Results of Onsite Inspection of Four Major Infant Formula Manufacturers

Take home:

CFDA conducted onsite inspection of four major infant formula manufacturers namely Weiquan, Beingmate, Wyeth Nutrition and Abbott. The results were published online and are available to the public.
Self-testing procedural issues, deviation from testing technical requirements and documentation errors were the main compliance failures uncovered during CFDA inspection.

In May of 2016, the CFDA organized a team to conduct onsite inspection of the production plants of four infant formula manufacturers, Weiquan, Beingmate, Wyeth Nutrition and Abbott. The inspection results were issued on the 8^th of November. The purpose of onsite inspection is to ensure full implementation of Chinese national requirements relating to food safety management systems and ensure full compliance with production requirements. The inspection schedule includes inspection of: production plants, documentation detailing safety management systems and onsite testing. All four manufacturers failed the inspection and were issued with a mandate to fix a number of problems. The main testing reference is listed below:

Major regulatory inspection reference:

A brief summary of the most important failures is introduced as follows:

Plant failures

Major requirements for plant layout are listed in the GB23760-2010. Frequent failures found by the authority include cross contamination of work areas and lack of a clear division between the work area and common work area. Workers were also found wearing the same work clothing in both the clean area and common work areas. Deviance from standards relating to ventilation facilities and/or inadequate ventilation in some clean work area or low ventilation volume was also highlighted.

Food safety management

Requirements for assessing the manufacturer’s food safety capabilities are detailed in the “Detailed Rules for Examination on Production Licensing for Baby Formula Manufacturers (here after called Detailed Rules)”.

The Detailed Rules include:

Safety management such as HACCP, GMP;
Management systems for major raw material, such as raw material supplier audit system,;
Purchasing system of raw materials
Recording system of technical standard and processing documents;
Formulation management;
Processing management;
Testing management;
Risk-control measures;
Raw material storage system;
Technical worker management;
Information management, product traceability and recall system;
R&D system.

Full self-testing capability is a requirement, but the Detailed Rules also require the manufacturer to verify and crosscheck self-testing results against the corresponding Chinese national standards. In many cases the testing reagents used during testing differed from those required by Chinese national testing standards. Another significant cause of failure related to lack of specific food safety management documents. In summary self-testing procedural issues, deviation from testing technical requirements and documentation errors were the main compliance failures uncovered during CFDA inspection.

On-site testing

GB 23790-2010 article 10.1 demands manufacturers should inspect the infant formula batch by batch against corresponding national standards. During the CFDA’s inspection, manufacturers were also required to conduct product testing onsite. 50% of manufacturers inspected by CFDA failed to meet requirements in this area.

Horizon Scanning: CFDA set to beef up inspection and enforcement of regulatory standards

Stringent supervision will be expanded from product inspection to plant inspection. The key principle is to see if the manufacturer is able to maintain consistent production conditions and consistently maintain compliance with Chinese national standards. These inspection likely foreshadow CFDA plans to greatly increase the frequency and stringency of onsite inspections. The endgame will see an increase in temporary production suspensions, product recalls and disruption in the supply chain of both domestic and international infant formula manufacturers in China.

Official notice

Inspection on Wyeth Nutrition

Inspection on Beingmate

Inspection on Weiquan

Inspection on Abbott